Liver CancerNCT05816837
Displacement Distance and Stabilization Time for Liver Fiducial Marker
An observational study of Liver Cancer, run by Peking University Third Hospital at 2 sites in China.
Trial summary
Liver malignant tumor, including liver cancer and liver metastasis, is common in China [1]. Previous studies have shown that cyber-knife stereotactic radiotherapy is effective and safe for locally advanced liver malignancies with improved local tumor control [2]. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cancer
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 20 Apr 2022to 19 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participant with liver tumors and plan to implant fiducial marker for radiatherapy.
Who may be able to join
- Ages 18 to 85
- Single or multiple liver tumors or mass (solid, partially solid)
- Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- Planned fiducial marker implantation with applicable puncture path
- With informed consent.
Who cannot join
- Poor organ function
- The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- Poor compliance, unable to complete coordination
- Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing, United Kingdom of Great Britain and Northern Ireland, 100010
Bin Qiu, 01082265968, 542122203@qq.com
- Recruiting
Department of Radiation Oncology of Peking university third hospital
Beijing
Bin Qiu, 01082265968, 542122203@qq.com
About this study
Liver malignant tumor, including liver cancer and liver metastasis, is common in China [1]. Previous studies have shown that cyber-knife stereotactic radiotherapy is effective and safe for locally advanced liver malignancies with improved local tumor control [2]. Real-time tumor tracking in cyber-knife stereotactic radiotherapy is currently used as tumors have respiratory movements [3]. At present, fiducial marker is used to realize the real-time track of tumor [4, 5]. However, the fiducial marker are likely to displacement usually within 7 days after implantation [4, 6, 7]. Therefore, simulated CT are delayed 7 days before the fiducial marker stabilization and significantly extend the radiotherapy planning process, increase the risk of tumor progression. As far as we know, there is no prospective study on the specific displacement distance and duration before the fiducial marker stabilization after implantation. Therefore, the purpose of this study was to study the displacement distance and stabilization time before stereotactic radiotherapy for liver malignant tumors guided by 3D printing template-assisted CT.
- B.K. Chang, R.D. Timmerman, Stereotactic body radiation therapy: a comprehensive review, Am J Clin Oncol 30 (6) (2007) 637-644.
- Kato Y, Kamomae T, Kumagai M, Oie Y, Noguchi Y, Okudaira K, et al. Hybrid 3D T1-weighted gradient-echo sequence for fiducial marker detection and tumor delineation via magnetic resonance imaging in liver stereotactic body radiation therapy. 2022;95:9-15.
- D.K. Bhasin, S.S. Rana, S. Jahagirdar, B. Nagi, Does the pancreas move with respiration? J Gastroenterol Hepatol 21 (9) (2006) 1424-1427.
- N. Kothary, J.J. Heit, J.D. Louie, W.T. Kuo, B.J. Loo, A. Koong, D.T. Chang, D. Hovsepian, D.Y. Sze, L.V. Hofmann, Safety and efficacy of percutaneous fiducial marker implantation for image-guided radiation therapy, J. Vasc. Interv. Radiol. 20 (2) (2009) 235-239.
- C.G. Trumm, S.M. Häussler, A. Muacevic, R. Stahl, S. Stintzing, P.M. Paprottka, F. Strobl, T.F. Jakobs, M.F. Reiser, R.T. Hoffmann, CT fluoroscopy-guided percutaneous fiducial marker placement for CyberKnife stereotactic radiosurgery: technical results and complications in 222 consecutive procedures, J. Vasc. Interv. Radiol. 25 (5) (2014) 760-768.
- Y. Seppenwoolde, W. Wunderink, V.S. Wunderink-van, P. Storchi, R.A. Méndez, B.J. Heijmen, Treatment precision of image-guided liver SBRT using implanted fiducial markers depends on marker-tumour distance, Phys. Med. Biol. 56 (17) (2011) 5445-5468.
- K. Valentine, T. Cabrera, D. Roberge, Implanting metal fiducials to guide stereotactic liver radiation: McGill experience and review of current devices, techniques and complications, Technol Cancer Res Treat 13 (3) (2014) 253-258.
- Conditions
- Liver Cancer
- Keywords
- liver cancer
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement distance
Fiducial marker displacement distance (millimeter) in the liver after implantation
Measured: Within 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Apr 2022
- Primary completion19 Apr 2024 (estimated)
- Study completion19 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Bin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816837
- Sponsor's protocol ID
- 3D-LVFM-1
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Displacement Distance and Stabilization Time for Liver Fiducial Marker
- ClinicalTrials.gov ID
- NCT05816837
- Acronym / sponsor ID
- 3D-LVFM-1
- Conditions
- Liver Cancer
- Keywords
- liver cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 19 Apr 2024 (estimated)
- Study completion
- 19 Apr 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver malignant tumor, including liver cancer and liver metastasis, is common in China [1]. Previous studies have shown that cyber-knife stereotactic radiotherapy is effective and safe for locally advanced liver malignancies with improved local tumor control [2]. Real-time tumor tracking in cyber-knife stereotactic radiotherapy is currently used as tumors have respiratory movements [3]. At present, fiducial marker is used to realize the real-time track of tumor [4, 5]. However, the fiducial marker are likely to displacement usually within 7 days after implantation [4, 6, 7]. Therefore, simulated CT are delayed 7 days before the fiducial marker stabilization and significantly extend the radiotherapy planning process, increase the risk of tumor progression. As far as we know, there is no prospective study on the specific displacement distance and duration before the fiducial marker stabilization after implantation. Therefore, the purpose of this study was to study the displacement distance and stabilization time before stereotactic radiotherapy for liver malignant tumors guided by 3D printing template-assisted CT.
- B.K. Chang, R.D. Timmerman, Stereotactic body radiation therapy: a comprehensive review, Am J Clin Oncol 30 (6) (2007) 637-644.
- Kato Y, Kamomae T, Kumagai M, Oie Y, Noguchi Y, Okudaira K, et al. Hybrid 3D T1-weighted gradient-echo sequence for fiducial marker detection and tumor delineation via magnetic resonance imaging in liver stereotactic body radiation therapy. 2022;95:9-15.
- D.K. Bhasin, S.S. Rana, S. Jahagirdar, B. Nagi, Does the pancreas move with respiration? J Gastroenterol Hepatol 21 (9) (2006) 1424-1427.
- N. Kothary, J.J. Heit, J.D. Louie, W.T. Kuo, B.J. Loo, A. Koong, D.T. Chang, D. Hovsepian, D.Y. Sze, L.V. Hofmann, Safety and efficacy of percutaneous fiducial marker implantation for image-guided radiation therapy, J. Vasc. Interv. Radiol. 20 (2) (2009) 235-239.
- C.G. Trumm, S.M. Häussler, A. Muacevic, R. Stahl, S. Stintzing, P.M. Paprottka, F. Strobl, T.F. Jakobs, M.F. Reiser, R.T. Hoffmann, CT fluoroscopy-guided percutaneous fiducial marker placement for CyberKnife stereotactic radiosurgery: technical results and complications in 222 consecutive procedures, J. Vasc. Interv. Radiol. 25 (5) (2014) 760-768.
- Y. Seppenwoolde, W. Wunderink, V.S. Wunderink-van, P. Storchi, R.A. Méndez, B.J. Heijmen, Treatment precision of image-guided liver SBRT using implanted fiducial markers depends on marker-tumour distance, Phys. Med. Biol. 56 (17) (2011) 5445-5468.
- K. Valentine, T. Cabrera, D. Roberge, Implanting metal fiducials to guide stereotactic liver radiation: McGill experience and review of current devices, techniques and complications, Technol Cancer Res Treat 13 (3) (2014) 253-258.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participant with liver tumors and plan to implant fiducial marker for radiatherapy.
Key inclusion criteria (6 listed)
- Ages 18 to 85
- Single or multiple liver tumors or mass (solid, partially solid)
- Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- KPS>60 points, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- Planned fiducial marker implantation with applicable puncture path
Key exclusion criteria (4 listed)
- Poor organ function
- The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- Poor compliance, unable to complete coordination
- Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Displacement distance
Time frame: Within 1 weeks
Fiducial marker displacement distance (millimeter) in the liver after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Radiation Oncology of Peking university third hospital
Beijing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement distance (time frame: Within 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.